From Idea to FDA Clearance: What Nobody Tells MedTech Founders with Darcy Bachert

Episode summary

Darcy Bachert shares experience developing medical device software through Prolucid Technologies. The discussion explores the practical work between an initial idea and regulatory clearance, including software quality and cybersecurity considerations that founders must address alongside building a functioning product.

Key points

• Medical device software development
• Cybersecurity alongside regulatory preparation
• Lessons from Prolucid Technologies